Job Description
Join BioMed Solutions Inc. at the forefront of medical innovation as we pioneer groundbreaking treatments for rare diseases. We're seeking a visionary Senior Clinical Research Manager to lead complex multi-center trials and shape the future of patient care. In this pivotal role, you'll collaborate with world-class researchers and industry leaders to transform scientific discoveries into life-changing therapies. Our state-of-the-art facilities in Boston's medical district offer unparalleled resources for cutting-edge research. What you'll achieve: Design and execute pivotal clinical trials, mentor cross-functional teams, and ensure regulatory compliance while driving therapeutic breakthroughs that impact millions globally. Why BioMed: Comprehensive benefits package, competitive compensation, and continuous professional development in an environment that values innovation and patient-centricity.
Responsibilities
- Lead end-to-end clinical trial management from protocol design to FDA submission
- Oversee budget execution and resource allocation for multi-center studies
- Ensure GCP/ICH compliance and regulatory documentation accuracy
- Collaborate with biostatisticians on data analysis and study endpoints
- Mentor junior researchers and cross-functional project teams
- Present trial outcomes to executive leadership and regulatory bodies
- Develop strategic partnerships with academic medical centers
Qualifications
- Master's degree in Clinical Research, Life Sciences, or related field
- 8+ years clinical research management experience in therapeutic areas
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record of leading Phase II-III oncology/neurology trials
- Expertise in FDA/EMA regulations and ICH-GCP guidelines
- Advanced proficiency in eClinical systems (Medidata Rave, Veeva Vault)
- Exceptional project management and stakeholder communication skills
- Experience with rare disease trial design and orphan drug pathways